Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02147158
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2014-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555622', 'term': 'ulipristal acetate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)', 'description': 'Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Treatment Course 1)', 'description': 'Matching placebo tablets, orally, once daily for 12 weeks in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 18, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'UPA 5 mg (Treatment Course 1)', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 38, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'UPA 10 mg (Treatment Course 1)', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 46, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'UPA 5 mg:Placebo (Treatment Course 2)', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by placebo matching tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 12, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'UPA 10 mg:Placebo (Treatment Course 2)', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 11, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'UPA 5 mg:UPA 5 mg (Treatment Course 2)', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 20, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'UPA 10 mg:UPA 10 mg (Treatment Course 2)', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 8, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Placebo:UPA 5 mg (Treatment Course 2)', 'description': 'Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 7, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Placebo:UPA 10 mg (Treatment Course 2)', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 9, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, 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'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Medical device site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.'}, {'id': 'OG001', 'title': 'UPA 5 mg', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.'}, {'id': 'OG002', 'title': 'UPA 10 mg', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.8'}, {'value': '42.0', 'groupId': 'OG001', 'lowerLimit': '33.3', 'upperLimit': '51.1'}, {'value': '54.8', 'groupId': 'OG002', 'lowerLimit': '45.5', 'upperLimit': '63.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last 35 consecutive days on treatment in the 12-Week Treatment Course 1', 'description': 'Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population included all randomized participants. Data was summarized as per the treatment assigned.'}, {'type': 'PRIMARY', 'title': 'Time to Absence of Bleeding on Treatment During Treatment Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.'}, {'id': 'OG001', 'title': 'UPA 5 mg', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.'}, {'id': 'OG002', 'title': 'UPA 10 mg', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and Confidence Interval (CI) were not estimable due to low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and CI upper limit were not estimable due to low number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '48.0', 'upperLimit': 'NA'}, {'value': '36.0', 'comment': 'CI upper limit was not estimable due to low number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose up to the end of the 12-Week Treatment Course 1', 'description': 'Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.', 'unitOfMeasure': 'days', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Data was summarized per treatment assigned.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.'}, {'id': 'OG001', 'title': 'UPA 5 mg', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.'}, {'id': 'OG002', 'title': 'UPA 10 mg', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.8'}, {'value': '34.6', 'groupId': 'OG001', 'lowerLimit': '26.3', 'upperLimit': '43.5'}, {'value': '55.4', 'groupId': 'OG002', 'lowerLimit': '46.2', 'upperLimit': '64.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 11 through the end of treatment in the 12-Week Treatment Course 1', 'description': 'Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), from Day 11 to the end of treatment in Treatment Course 1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Data was summarized as per the treatment assigned.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'OG001', 'title': 'UPA 5 mg', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'OG002', 'title': 'UPA 10 mg', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '17.9'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '28.5', 'upperLimit': '53.3'}, {'value': '57.3', 'groupId': 'OG002', 'lowerLimit': '44.4', 'upperLimit': '69.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last 35 consecutive days on treatment in the 12-Week Treatment Course 2', 'description': 'Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 2.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was summarized as per the treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Time to Absence of Bleeding on Treatment During Treatment Course 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'OG001', 'title': 'UPA 5 mg', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'OG002', 'title': 'UPA 10 mg', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and CI were not estimable due to low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and CI upper limit were not estimable due to low number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '37.0', 'upperLimit': 'NA'}, {'value': '7.5', 'comment': 'CI upper limit was not estimable due to low number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose up to the end of treatment in the 12-Week Treatment Course 2', 'description': 'Time to absence of bleeding is defined as the duration in days from first dose in treatment course 2 to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the second treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 2.', 'unitOfMeasure': 'days', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was summarized as per treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.'}, {'id': 'OG001', 'title': 'UPA 5 mg', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.'}, {'id': 'OG002', 'title': 'UPA 10 mg', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '28.70', 'spread': '24.56', 'groupId': 'OG000'}, {'value': '27.52', 'spread': '24.05', 'groupId': 'OG001'}, {'value': '33.24', 'spread': '27.00', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '14.25', 'spread': '28.77', 'groupId': 'OG000'}, {'value': '50.19', 'spread': '32.07', 'groupId': 'OG001'}, {'value': '54.73', 'spread': '32.32', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1-4) to End of 12-Week Treatment Course 1', 'description': "The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was summarized as per treatment assigned and included all participants with data at both Baseline and Week 12 in Treatment Course 1.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'UPA 5 mg:Placebo', 'description': 'Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'FG001', 'title': 'UPA 10 mg:Placebo', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'FG002', 'title': 'UPA 5 mg:UPA 5 mg', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.'}, {'id': 'FG003', 'title': 'UPA 10 mg:UPA 10 mg', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.'}, {'id': 'FG004', 'title': 'Placebo:UPA 5 mg', 'description': 'Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'FG005', 'title': 'Placebo:UPA 10 mg', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.'}], 'periods': [{'title': 'Treatment Course 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '110'}, {'groupId': 'FG004', 'numSubjects': '55'}, {'groupId': 'FG005', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '97'}, {'groupId': 'FG004', 'numSubjects': '49'}, {'groupId': 'FG005', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}, {'title': 'Off-Treatment Interval 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '97'}, {'groupId': 'FG004', 'numSubjects': '49'}, {'groupId': 'FG005', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '82'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Course 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '82'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '77'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Off-Treatment Interval 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '77'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '66'}, {'groupId': 'FG004', 'numSubjects': '39'}, {'groupId': 'FG005', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '432', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'UPA 5 mg:Placebo', 'description': 'Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'BG001', 'title': 'UPA 10 mg:Placebo', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'BG002', 'title': 'UPA 5 mg:UPA 5 mg', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.'}, {'id': 'BG003', 'title': 'UPA 10 mg:UPA 10 mg', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.'}, {'id': 'BG004', 'title': 'Placebo:UPA 5 mg', 'description': 'Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'BG005', 'title': 'Placebo:UPA 10 mg', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '41.8', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '40.9', 'spread': '6.6', 'groupId': 'BG002'}, {'value': '41.0', 'spread': '5.3', 'groupId': 'BG003'}, {'value': '40.8', 'spread': '5.1', 'groupId': 'BG004'}, {'value': '40.7', 'spread': '4.6', 'groupId': 'BG005'}, {'value': '41.0', 'spread': '5.6', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '432', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-Treat (ITT) population included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 432}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'dispFirstSubmitDate': '2017-11-03', 'completionDateStruct': {'date': '2016-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-15', 'studyFirstSubmitDate': '2014-05-10', 'dispFirstSubmitQcDate': '2017-11-03', 'resultsFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2014-05-21', 'dispFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-15', 'studyFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1', 'timeFrame': 'Last 35 consecutive days on treatment in the 12-Week Treatment Course 1', 'description': 'Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.'}, {'measure': 'Time to Absence of Bleeding on Treatment During Treatment Course 1', 'timeFrame': 'From first dose up to the end of the 12-Week Treatment Course 1', 'description': 'Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1', 'timeFrame': 'Day 11 through the end of treatment in the 12-Week Treatment Course 1', 'description': 'Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), from Day 11 to the end of treatment in Treatment Course 1.'}, {'measure': 'Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2', 'timeFrame': 'Last 35 consecutive days on treatment in the 12-Week Treatment Course 2', 'description': 'Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 2.'}, {'measure': 'Time to Absence of Bleeding on Treatment During Treatment Course 2', 'timeFrame': 'From first dose up to the end of treatment in the 12-Week Treatment Course 2', 'description': 'Time to absence of bleeding is defined as the duration in days from first dose in treatment course 2 to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the second treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 2.'}, {'measure': 'Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1', 'timeFrame': 'Baseline (Day 1-4) to End of 12-Week Treatment Course 1', 'description': "The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leiomyoma', 'Uterine Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '31444600', 'type': 'DERIVED', 'citation': 'Coyne KS, Harrington A, Currie BM, Chen J, Gillard P, Spies JB. Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL). J Patient Rep Outcomes. 2019 Aug 23;3(1):57. doi: 10.1186/s41687-019-0146-x.'}, {'pmid': '30969201', 'type': 'DERIVED', 'citation': 'Lukes AS, Soper D, Harrington A, Sniukiene V, Mo Y, Gillard P, Shulman L. Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):869-878. doi: 10.1097/AOG.0000000000003211.'}, {'pmid': '30303900', 'type': 'DERIVED', 'citation': 'Liu JH, Soper D, Lukes A, Gee P, Kimble T, Kroll R, Mallick M, Chan A, Gillard P, Harrington A, Sniukiene V, Shulman LP. Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1241-1251. doi: 10.1097/AOG.0000000000002942.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females suffering with abnormal uterine bleeding associated with leiomyomas were treated in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal women, 18-50 years, inclusive.\n* Cyclic abnormal uterine bleeding (heavy or prolonged).\n* Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.\n* Minimum of one discrete leiomyoma observable by transvaginal ultrasound.\n* Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia.\n\nExclusion Criteria:\n\n* History of uterine surgery that would interfere with the study endpoints.\n* Known coagulation disorder including bleeding disorder or clotting disorder.\n* History of, or current uterine, cervix, ovarian, or breast cancer.\n* Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal range.'}, 'identificationModule': {'nctId': 'NCT02147158', 'briefTitle': 'A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas', 'orgStudyIdInfo': {'id': 'UL1208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UPA 5 mg:Placebo', 'description': 'Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.', 'interventionNames': ['Drug: Ulipristal acetate (UPA)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'UPA 10 mg:Placebo', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.', 'interventionNames': ['Drug: Ulipristal acetate (UPA)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'UPA 5 mg:UPA 5 mg', 'description': 'UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.', 'interventionNames': ['Drug: Ulipristal acetate (UPA)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'UPA 10 mg:UPA 10 mg', 'description': 'UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.', 'interventionNames': ['Drug: Ulipristal acetate (UPA)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo:UPA 5 mg', 'description': 'Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.', 'interventionNames': ['Drug: Ulipristal acetate (UPA)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo:UPA 10 mg', 'description': 'Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.', 'interventionNames': ['Drug: Ulipristal acetate (UPA)', 'Drug: Placebo']}], 'interventions': [{'name': 'Ulipristal acetate 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